—#44133

Product

UniCel Dxl 800 Access Immunoassay System Software Versions 2.2.1 and earlier

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K023764
Affected lot / code info: Part Numbers: 386162 (software) 973100 (Instrument), Software Versions 2.2.1 and earlier.

Why it was recalled

The UniCel Dxl 800 Access Immunoassay may aspirate a sample from an incorrect rack and generate a result, which is not flagged (under a specific set of circumstances)

Root cause (FDA determination)

Software design

Action the firm took

A Product Corrective Action letter will be mailed the week of Feb 06 2006 to all UniCel 800 Dxl customers informing them of a rare condition on the UniCel Dxl 800 Access Immunoassay Systems. Under a specific set of circumstances, the UniCel Dxl 800 may aspirate a sample from an incorrect rack and generate a result, which is not flagged. (Letter is sent by US mail)

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern: Nationwide and Canada

Timeline

Recall initiated: 2006-02-06
Posted by FDA: 2006-03-03
Terminated: 2012-03-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #44133. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.